Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried t...Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried to assess if stent performance might be improved if the off-label character-istics present were taken into account to guide the stent brand selection. Design: A total of 2888 coronary lesions treated with first generation drug eluting stents were classified for eventual presence of 18 different off-label characteristics and correlated to the 5-year clinical outcome by multiple stepwise Cox regression analysis. Results: The composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE) was 16.7% in cases with zero off-label characteristics and showed a stepwise increased rate up to 32.7% in cases with 5 off-label characteristics. The MACE rate for the sirolimus eluting stent appears to be 10% lower than the paclitaxel stent group and it may be further reduced by 10% - 18% if the off-label characteristics present in each case were taken into account to guide the stent brand selection. Conclusion: With increasing number of concomitantly appearing off-label characteristics there is a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label characteristics were used to guide the stent brand selection.展开更多
Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and impro...Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8± 10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P 〈 0.001) or side branch (14.5% vs 37.0%, P 〈 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P =0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P 〈 0.001) and for side branch (7.6% vs 23.5%, P 〈 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P =0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.展开更多
Background Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were s...Background Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were selected. From October 2003 to June 2005, 112 patients with 113 bifurcation lesions were treated by two drug eluting stents (DESs), technique. The location of bifurcation lesions were left anterior descending coronary artery/diagonal in 62 patients, left main distal bifurcation in 32, left circumflex coronary artery/obtute marginal branch in 18 and right coronary artery distal bifurcation in 1. Procedures for bifurcation lesions were crush or modified crush technique in 64, "T" stenting technique in 27, modified "Y" stenting, kiss stenting, "V" stenting as well as culotte stenting technique in 11, 5, 3 and 3, respectively. Among 226 lesions, 91 Cypher or Cypher select stents, 74 TAXUS and 67 Firebird were used. Final kiss balloon dilation was performed in 60 (93.7%) with crush technique after stenting. Results Success rate of percutaneous coronary intervention for the bifurcation lesions was 100%. One patient, who developed inhospital acute myocardial infarction due to subacute thrombosis, was successfully treated by a second intervention. Major adverse cardiac events rate in-hospital was 0.89% (1/112) and during followup was 7.14% (8/112), No death occurred during the followup of all patients. Angiographic followup was effected for 46 patients, restenosis for eight, coronary artery bypass grafting for 1 and a repeat intervention for 5. Restenosis involving TAXUS, Cypher and Firebird was 5 (5/18, 27.8%), 2 (2/17, 11.8%) and 1 (1/11, 9.1%), respectively (P〉0.05). Total restenotic rate was 17.4% (8/46). Conclusions When ostium of side branch has severe stenosis and 〉12.5 mm in diameter, two-stent strategy in this bifurcation lesion is safe and effective, and the outcomes are satisfactory. Restenotic rates were not different between TAXUS, Cypher and Firebird DESs.展开更多
BACKGROUND We performed a meta-analysis on observational studies since randomized control trials are not available.We studied intracoronary brachytherapy(ICBT)and recurrent drug eluting stent in-stent restenosis(DES-I...BACKGROUND We performed a meta-analysis on observational studies since randomized control trials are not available.We studied intracoronary brachytherapy(ICBT)and recurrent drug eluting stent in-stent restenosis(DES-ISR)to evaluate the procedural success,target lesion revascularization(TLR),incidence of myocardial infarction(MI)and all-cause mortality at 2 years follow-up.AIM To perform meta-analysis for patients undergoing ICBT for recurrent DES-ISR.METHODS We performed a systematic search of the PubMed/MEDLINE,Cochrane and DARE databases to identify relevant articles.Studies were excluded if intracoronary brachytherapy was used as a treatment modality for initial ISR and studies with bare metal stents.We used a random-effect model with DerSimonian&Laird method to calculate summary estimates.Heterogeneity was assessed using I2 statistics.RESULTS A total of 6 observational studies were included in the final analysis.Procedural angiographic success following intra-coronary brachytherapy was 99.8%.Incidence of MI at 1-year was 2%and 4.1%at 2-years,respectively.The incidence of TLR 14.1%at 1-year and 22.7%at 2-years,respectively.All-cause mortality at 1-and 2-year follow-up was 3%and 7.5%,respectively.CONCLUSION Given the observational nature of the studies included in the analysis,heterogeneity was significantly higher for outcomes.While there are no randomized controlled trials or definitive guidelines available for recurrent ISR associated with DES,this analysis suggests that brachytherapy might be the alternative approach for recurrent DES-ISR.Randomized controlled trials are required to confirm results from this study.展开更多
BACKGROUND Drug-eluting stents(DES)are used to treat lower extremity arterial disease.During DES treatment,aneurysmal degeneration occasionally occurs,especially with fluoropolymer-based DES.However,the incidence of p...BACKGROUND Drug-eluting stents(DES)are used to treat lower extremity arterial disease.During DES treatment,aneurysmal degeneration occasionally occurs,especially with fluoropolymer-based DES.However,the incidence of pseudoaneurysms after DES placement is rarely reported in the lower extremity region,although there have been several reports on pseudoaneurysm formation after DES placement in the coronary artery region.CASE SUMMARY We report the case of a 64-year-old man who presented with fever and pain in his left hand after dialysis.Bacteremia was diagnosed by blood culture,and after admission,he developed pain on the medial side of the right thigh.A pseudoaneurysm was observed in the right superficial femoral artery(SFA)at the proximal end of a previously placed DES.The bacteremia was thought to have been caused by a pseudoaneurysm of the left superficial brachial artery,and the pseudoaneurysm of the left superficial brachial artery was removed after antibiotic treatment.The pseudoaneurysm of the right SFA rapidly expanded after admission,but the expansion rate was reduced after infection control.Seven months after the first admission,the pseudoaneurysm of the left SFA was re-moved and in situ revascularization performed using a rifampicin-soaked Dacron graft.CONCLUSION Although pseudoaneurysm after DES placement in the lower extremity region is rare,it must be considered in patients with bacteremia.展开更多
Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polyme...Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polymer-free stent system with nanotechnology and elutes rapamycin (1.6 μg/mm2) and probucol (0.8 μg/mm2). The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography (OCT) findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.展开更多
Long coronary lesions are associated with adverse outcomes after percutaneous coronary intervention since the era of plain balloon angioplasty. Long lesion and long stent length are considered as important predictors ...Long coronary lesions are associated with adverse outcomes after percutaneous coronary intervention since the era of plain balloon angioplasty. Long lesion and long stent length are considered as important predictors of restenosis after percutaneous coronary intervention. With the advent of newer generation drug eluting stents, there has been dramatic reduction in the rates of restenosis and repeat revascularization, even in complex cohort of patients with long coronary lesions. We report one such case of long coronary lesion which was intervened successfully with newer generation, thin strut, biodegradable polymer coated sirolimus-eluting stents.展开更多
Background There are limited data on the efficacy of drug-eluting stents (DES) for treatment of chronic total occlusions (CTO). The aim of the study was to evaluate the long-term clinical outcomes of DES implantat...Background There are limited data on the efficacy of drug-eluting stents (DES) for treatment of chronic total occlusions (CTO). The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent (BMS) implantation.Methods Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 (55.7%) who underwent DES and 524 (44.3%) who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events (MACE). Long-term survival rates were estimated with the Kaplan-Meier method.Results Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy ((7.4±2.5) months vs (1.7±0.8) months, P 〈0.001). Average follow-up periods were (4.7±0.89) and (3.2±1.3) years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups (90.3% for DES group vs 89.6% for BMS group, Log-rank P=0.38), but the 5-year target vessel revascularization (TVR)-free survival rate in the DES group was significantly higher than that in the BMS group (81.6% vs 73.5%, Log-rank P 〈0.001). The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group (80.6% vs 71.5%, Log-rank P〈0.001). The rates of readmission caused by cardiovascular disease (27.0% vs 37.8%, P 〈0.001) and the need for bypass surgery were significantly lower in the DES group (1.5% vs 3.4%, P 〈0.05). By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients (HR: 0.492; 95% Cl 0.396-0.656, P 〈0.001). Left ventricular ejection fraction 〈50% and elderly (〉65 years) were identified as independent predictors of long-term MACE during follow-up.Conclusion This study demonstrates the long-term (up to 5 years) efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.展开更多
Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%' Small diameter renal artery is common in patients with congenital mul...Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%' Small diameter renal artery is common in patients with congenital multi-branch renal arteries, diabetes and multi-coronary artery lesions. Renal artery bare-mental stent (BMS) implantation is the standard treatment for ostial renal展开更多
Background Because no data regarding the comparison of crush stenting with paclitaxel (PES) or sirolimus eluting stents (SES) for coronary bifurcate lesions have been reported, we compared the clinical outcomes of...Background Because no data regarding the comparison of crush stenting with paclitaxel (PES) or sirolimus eluting stents (SES) for coronary bifurcate lesions have been reported, we compared the clinical outcomes of these two types of stents. Methods Two hundred and thirty patients with 242 bifurcate lesions were enrolled in a prospective, nonrandomized trial Primary endpoints included myocardial infarction, cardiac death and target vessel revascularization at 8 months. Results All patients were followed up clinically and 82% angiographically at 8 months. Final kissing balloon inflation was performed in 72% in the PES and 75% in the SES groups (P〉0.05). Compared to the SES group, PES group had a higher late loss and incidence of restenosis (P=0.04) in the prebifurcation vessel segment. The postbifurcation vessel segment in the PES group had a greater late loss ((0.7±0.6) mm vs (0.3±0.4) mm, P〈0.001) and higher restenosis in the side branch (25.5% vs 15.6%, P=0.04) when compared to the SES group. There was significant difference of insegment restenosis in the entire main vessel between PES and SES groups (P=0.004). Target lesion revascularization was more frequently seen in the PES group as compared to the SES group (P=0.01). There was significant difference in the accumulative MACE between these two groups (P=-0.01). The survival rate free from target lesion revascularization was significantly higher in the SES group when compared to the PES group (P〈0.001). Conclusion SES is superior to PES in reducing restenosis and target lesion revascularization by 8-month follow-up after crush stenting for bifurcate lesions.展开更多
Background Drug-eluting stents (DES) are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular ...Background Drug-eluting stents (DES) are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular the late and very late stent thrombosis rate compared to bare metal stents (BMS). The aim of the study was to compare the reported incidence of late and very late stent thrombosis of DES and BMS in patients from published clinical studies with an extended follow-up period to four years.Methods A search strategy was developed to identify publications reporting on late or very late thrombosis of BMS and DES available through MEDLINE and Cochrane Library databases. Two independent reviewers appraised eligible studies and extracted data. Odds ratios (OR) were calculated for each outcome and presented with 95% confidence intervals (CI).Results Fourteen randomized controlled trials, which were at least single blinded, were identified. There was no difference in the incidence of late and very late stent thrombosis in patients treated with DES compared with patients treated with BMS (late OR 0.55, 95%Cl 0.23-1.31 and late/very late OR=1.08, 95%CI 0.61-1.91).Conclusions The safety profile of DES was similar to BMS in terms of stent thrombosis. We found no evidence of increased risk of late and very late thrombosis for DES.展开更多
Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of t...Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG)in the patients with CTO and multivessel disease.Methods From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.Results At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% Cl 1.219-3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739-45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.Conclusions Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.展开更多
The objective of this study is to develop a cost-effectiveness model comparing drug eluting stents(DES) vs bare metal stent(BMS) in patients suffering of stable coronary artery disease. Using a 2-years time horizon, t...The objective of this study is to develop a cost-effectiveness model comparing drug eluting stents(DES) vs bare metal stent(BMS) in patients suffering of stable coronary artery disease. Using a 2-years time horizon, two simulation models have been developed: BMS first line strategy and DES first line strategy. Direct medical costs were estimated considering ambulatory and hospital costs. The effectiveness endpoint was defined as treatment success, which is the absence of major adverse cardiac events. Probabilistic sensitivity analyses were carried out using 10000 Monte-Carlo simulations. DES appeared slightly more efficacious over 2 years(60% of success) when compared to BMS(58% of success). Total costs over 2 years were estimated at 9303 € for the DES and at 8926 € for bare metal stent. Hence, corresponding mean cost-effectiveness ratios showed slightly lower costs(P < 0.05) per success for the BMS strategy(15520 €/success), as compared to the DES strategy(15588 €/success). Incremental costeffectiveness ratio is 18850 € for one additional percent of success. The sequential strategy including BMS as the first option appears to be slightly less efficacious but more cost-effective compared to the strategy including DES as first option. Future modelling approaches should confirm these results as further comparative data in stable coronary artery disease and long-term evidence become available.展开更多
Atherosclerotic process has a predilection for .bifurcation due to the complex hemodynamics and resultant altered shear stress that contributes to the localization and progression of atheromatous plaques. Coronary int...Atherosclerotic process has a predilection for .bifurcation due to the complex hemodynamics and resultant altered shear stress that contributes to the localization and progression of atheromatous plaques. Coronary intervention, especially the placement of stents further alters the hemodynamics and shear forces. These factors may account for the increased incidences of in-stent restenosis, stent thrombosis, side-branch (SB) restenosis, etc, that continue to plague bifurcation intervention.展开更多
Objective To review the presentation,diagnosis and recent developments in the pharmacological and invasive treatment of ST elevation myocardial infarction (STEMI) with a special focus on health-care organization in or...Objective To review the presentation,diagnosis and recent developments in the pharmacological and invasive treatment of ST elevation myocardial infarction (STEMI) with a special focus on health-care organization in order to increase accessibility of primary pemutaneous coronary intervention (PCI).Data sources Data were obtained from English publications on STEMI treatment.No formal systematic review was conducted,but an effort was made to be comprehensive.Study selection Studies were selected if they contained data relevant to the topic.Preferably,data from clinical randomized trials,meta-analyses,guidelines and a few recent reviews are referenced.Results The described clinical approach to acute myocardial infarction (AMI) has been a continuum of scientific results and translation into clinical practice over the last four decades since the advent of thrombolytic reperfusion.This has resulted in a dramatic in-hospital mortality decrease from 30% in the 1960s to the present 5%.The biggest survival benefits have undoubtedly been achieved after the advent of reperfusion strategies.In contemporary treatment of STEMI,additional treatment effects on survival have to be sought in the very early admission phase,as the current mortality hazard drops significantly after the first critical days to continuously very low levels after discharge.Conclusions Optimal treatment of STEMI patients is best performed with a widely accessible reperfusion strategy,preferably primary PCI,with contemporary peri-procedural anti-thrombotic treatment and device implantation.Accessibility of reperfusion strategies is increased by efficient STEMI networks applying prehospital triage with digital tele-transmission of electrocardiograms (ECGs) and seamless patient transitions between health-care unities.Efficient treatments of complicated STEMI with out-of hospital cardiac arrest and/or cardiogenic shock underline the necessity of structured referral systems,preferably immediately after the initial STEMI diagnosis。展开更多
Background Early clinical trials with the Endeavor zotarolimus eluting stent (ZES) in western populations demonstrated low rates of target lesion revascularization with a favorable safety profile including low late ...Background Early clinical trials with the Endeavor zotarolimus eluting stent (ZES) in western populations demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 5 years of follow-up. The aim of this clinical registry study was to evaluate real world clinical performance of the ZES coronary system in Chinese patients. Methods The China Endeavor Registry is a prospective, multicenter registry assessing the safety of the ZES system in a real world patient population. It was conducted at 46 centers in China in routine treatment of patients with coronary artery stenosis, including patients with clinical characteristics or lesion types that are often excluded from randomized controlled trials. The registry included 2210 adult patients who underwent single-vessel or multi-vessel percutaneous coronary intervention. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. Results The 12-month rate of MACE for all patients in the registry was 3.03%. Cardiac death or myocardial infarction rate was 1.28% and target lesion revascularization rate was 1.66%, non-target lesion target vessel revascularization (TVR) was 0.52%, TVR was 2.18%, and target vessel failure was 3.22%. There was only one case of emergent cardiac bypass surgery. The 12-month overall incidence of all Academic Research Consortium (ARC)-defined stent thrombosis was 0.43%. Conclusion Mid-term results from the real-world China Endeavor Registry suggest that Endeavor ZES was safe and effective in Chinese patients.展开更多
Background Through a ministernotomy "J shaped approach, left internal mammary artery (LIMA) bypass grafting to the left anterior descending artery (LAD) can be performed safely off-pump. To achieve a complete rev...Background Through a ministernotomy "J shaped approach, left internal mammary artery (LIMA) bypass grafting to the left anterior descending artery (LAD) can be performed safely off-pump. To achieve a complete revascularization, percutaneous coronary interventions (PCI) with drug eluting stent implantation to other coronary arteries was used. We reported outcomes of the treatment of multivessel coronary artery disease with minimally invasive coronary artery bypass (MICAB) and PCI. Methods Between January 2009 and Dec 2012, 14 patients (11 males, 3 females, mean age was 64.8 _ 10.1 years. Two-vessel disease account for 35.7% (5/14) of these patients, three-vessel disease 64.2% (9/14) (Table 1). All patients underwent a minimally invasive coronary artery bypass grafting via mini-sternotomy "J" shaped approach. Seven patients were followed by PCI, 7 for obtuse marginal circumflex, 5 for right coronary artery (RCA). Angiographic assessment of graft patency was performed in all patients during the PCI procedure. The clinical follow-up period lasts from 11-24 months. Results The in-hospital mortality was 0%. There was neither conversion to a full median sternotomy nor intraoperative complications. Ventilation time was 6.6 +_ 4.1 h. Blood loss ranged 341 +_ 78.8 mL. ICU stay ranged 22.3 _ 12.8 h. Hospital postoperative stay lasted for 6.5 + 1.6 days. Prior to PCI patients showed 100% patent left internal mammary artery. One patient had mediastinitis (Tables 2-3). Rate of freedom from cardiac reintervention during the follow-up period was 92.8% (13/14). Conclusions The inferior J-shaped sternotomy is simple, reproducible, and the safest technique for performing minimally invasive coronary bypass surgery. MICAB + PCI is also safe, feasible and efficacious.展开更多
Background Patients with end-stage renal disease have a high mortality from coronary artery disease, but the impact of moderate renal insufficiency on clinical outcomes after percutaneous coronary intervention (PCI)...Background Patients with end-stage renal disease have a high mortality from coronary artery disease, but the impact of moderate renal insufficiency on clinical outcomes after percutaneous coronary intervention (PCI) and the effect of drug-eluting stent implantation in these patients remain unclear. This study determined the long-term effect of moderate renal insufficiency on death and major adverse cardiac events (MACE) after stent based PCI and examined whether drug-eluting stent implantation could favourably influence clinical outcome. Methods Major adverse cardiac events and causes of mortality were determined for 1012 patients undergoing percutaneous intervention from January 1, 2002 to December 31, 2004 at Shanghai Ruijin Hospital. Based on estimated creatinine clearance levels, long term outcomes were compared between patients with estimated creatinine clearance 〈60 ml/min (renal insufficiency group; n=410) and those with estimated creatinine clearance ≥60 ml/min (control group; n=602). Subgroup analysis was also made for patients with renal insufficiency between drug eluting stent (n=264) and bare metal stent implantation (n=146) during PCI. Results During follow-up (average 17 months) after successful PCI, all causes of death (7.1% vs 2.3%, P〈0.01) and cardiac death (3.4% vs 1.0%, all P〈0.01) were significantly higher in renal insufficiency group than in control group. For patients with moderate renal insufficiency, drug-eluting stent implantation reduced significantly all causes of death (5.3% vs 10.9%, P〈0.05) and occurrence of major cardiac adverse events (15.1% vs 24.6%, P〈0.05) compared with bare metal stents. Conclusions Moderate renal insufficiency is an important clinical factor influencing the mortality after PCI in patients with coronary artery disease and the use of drug-eluting stents should be the preferred therapy for the improvement of long-term outcomes in such patients.展开更多
Background Lesions at coronary bifurcations always are a big challenge for interventionists even with the advent of drug eluting stents (DES). Even as more clinical trials are published, operators still can not conf...Background Lesions at coronary bifurcations always are a big challenge for interventionists even with the advent of drug eluting stents (DES). Even as more clinical trials are published, operators still can not confirm that one strategy is more efficient than another. Selection of patients and short term follow-up contribute to the difficulty in comparing strategies. Methods From April 2004 to April 2008, 505 consecutive Chinese patients underwent DES implantation for true bifurcation lesions; including 258 using crush strategy (213 male, (56.7+10.8) years old) and 247 using no crush strategy (206 male, (58.1+10.1) years old) were analyzed. Results The follow-up period ranged from 237 to 1223 days, average (537+340) days for the crush group and (538+351) days for the no crush group. There was no significant difference of major adverse cardiac events (MACE) rate between the two groups (10.1% vs 12.1%; P=-0.481), nor in cardiac death, nonfatal myocardial infarction (MI) or in the target vessel revascularization (TVR) (0.4% vs 1.6%; P=0.207, 2.7% vs 2.8; P=1.000 and 7.0% vs 7.7%; P=0.865). The stent thrombosis rate was similar in the two groups (1.6% vs 2.0%; P=0.409), late and very late stent thrombosis in both groups were very low (0.4% vs 0.4%; P=-1.000). Seven-month angiographic follow-up showed no significant difference of the restenosis rate between the two groups (11.0% vs 13.5%; P=0.786). During the follow-up, cardiac death, nonfatal MI, TVR and ST free survival rate showed no significant difference between the two groups. The only variant identified as a predictor of MACE was percutaneous coronary intervention (PCI) in the first two years, which accounted for 47% of patients of all cases in four years. Conclusion Crush technique showed similar long-term clinical effect compared with other two DES techniques for coronary bifurcation lesions, the surgeons' skills are very important for reducing clinical events.展开更多
文摘Objective: We explored the impact of increasing number of off-label patient and lesion character-istics on 5-year clinical outcome following implantation of first generation drug eluting stents. Furthermore we tried to assess if stent performance might be improved if the off-label character-istics present were taken into account to guide the stent brand selection. Design: A total of 2888 coronary lesions treated with first generation drug eluting stents were classified for eventual presence of 18 different off-label characteristics and correlated to the 5-year clinical outcome by multiple stepwise Cox regression analysis. Results: The composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE) was 16.7% in cases with zero off-label characteristics and showed a stepwise increased rate up to 32.7% in cases with 5 off-label characteristics. The MACE rate for the sirolimus eluting stent appears to be 10% lower than the paclitaxel stent group and it may be further reduced by 10% - 18% if the off-label characteristics present in each case were taken into account to guide the stent brand selection. Conclusion: With increasing number of concomitantly appearing off-label characteristics there is a stepwise increase in MACE rate. The MACE rate may be reduced if the off-label characteristics were used to guide the stent brand selection.
文摘Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8± 10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P 〈 0.001) or side branch (14.5% vs 37.0%, P 〈 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P =0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P 〈 0.001) and for side branch (7.6% vs 23.5%, P 〈 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P =0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.
文摘Background Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were selected. From October 2003 to June 2005, 112 patients with 113 bifurcation lesions were treated by two drug eluting stents (DESs), technique. The location of bifurcation lesions were left anterior descending coronary artery/diagonal in 62 patients, left main distal bifurcation in 32, left circumflex coronary artery/obtute marginal branch in 18 and right coronary artery distal bifurcation in 1. Procedures for bifurcation lesions were crush or modified crush technique in 64, "T" stenting technique in 27, modified "Y" stenting, kiss stenting, "V" stenting as well as culotte stenting technique in 11, 5, 3 and 3, respectively. Among 226 lesions, 91 Cypher or Cypher select stents, 74 TAXUS and 67 Firebird were used. Final kiss balloon dilation was performed in 60 (93.7%) with crush technique after stenting. Results Success rate of percutaneous coronary intervention for the bifurcation lesions was 100%. One patient, who developed inhospital acute myocardial infarction due to subacute thrombosis, was successfully treated by a second intervention. Major adverse cardiac events rate in-hospital was 0.89% (1/112) and during followup was 7.14% (8/112), No death occurred during the followup of all patients. Angiographic followup was effected for 46 patients, restenosis for eight, coronary artery bypass grafting for 1 and a repeat intervention for 5. Restenosis involving TAXUS, Cypher and Firebird was 5 (5/18, 27.8%), 2 (2/17, 11.8%) and 1 (1/11, 9.1%), respectively (P〉0.05). Total restenotic rate was 17.4% (8/46). Conclusions When ostium of side branch has severe stenosis and 〉12.5 mm in diameter, two-stent strategy in this bifurcation lesion is safe and effective, and the outcomes are satisfactory. Restenotic rates were not different between TAXUS, Cypher and Firebird DESs.
文摘BACKGROUND We performed a meta-analysis on observational studies since randomized control trials are not available.We studied intracoronary brachytherapy(ICBT)and recurrent drug eluting stent in-stent restenosis(DES-ISR)to evaluate the procedural success,target lesion revascularization(TLR),incidence of myocardial infarction(MI)and all-cause mortality at 2 years follow-up.AIM To perform meta-analysis for patients undergoing ICBT for recurrent DES-ISR.METHODS We performed a systematic search of the PubMed/MEDLINE,Cochrane and DARE databases to identify relevant articles.Studies were excluded if intracoronary brachytherapy was used as a treatment modality for initial ISR and studies with bare metal stents.We used a random-effect model with DerSimonian&Laird method to calculate summary estimates.Heterogeneity was assessed using I2 statistics.RESULTS A total of 6 observational studies were included in the final analysis.Procedural angiographic success following intra-coronary brachytherapy was 99.8%.Incidence of MI at 1-year was 2%and 4.1%at 2-years,respectively.The incidence of TLR 14.1%at 1-year and 22.7%at 2-years,respectively.All-cause mortality at 1-and 2-year follow-up was 3%and 7.5%,respectively.CONCLUSION Given the observational nature of the studies included in the analysis,heterogeneity was significantly higher for outcomes.While there are no randomized controlled trials or definitive guidelines available for recurrent ISR associated with DES,this analysis suggests that brachytherapy might be the alternative approach for recurrent DES-ISR.Randomized controlled trials are required to confirm results from this study.
文摘BACKGROUND Drug-eluting stents(DES)are used to treat lower extremity arterial disease.During DES treatment,aneurysmal degeneration occasionally occurs,especially with fluoropolymer-based DES.However,the incidence of pseudoaneurysms after DES placement is rarely reported in the lower extremity region,although there have been several reports on pseudoaneurysm formation after DES placement in the coronary artery region.CASE SUMMARY We report the case of a 64-year-old man who presented with fever and pain in his left hand after dialysis.Bacteremia was diagnosed by blood culture,and after admission,he developed pain on the medial side of the right thigh.A pseudoaneurysm was observed in the right superficial femoral artery(SFA)at the proximal end of a previously placed DES.The bacteremia was thought to have been caused by a pseudoaneurysm of the left superficial brachial artery,and the pseudoaneurysm of the left superficial brachial artery was removed after antibiotic treatment.The pseudoaneurysm of the right SFA rapidly expanded after admission,but the expansion rate was reduced after infection control.Seven months after the first admission,the pseudoaneurysm of the left SFA was re-moved and in situ revascularization performed using a rifampicin-soaked Dacron graft.CONCLUSION Although pseudoaneurysm after DES placement in the lower extremity region is rare,it must be considered in patients with bacteremia.
文摘Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE (Lepu Medical Technology Co., Ltd, Beijing, China) is a novel polymer-free stent system with nanotechnology and elutes rapamycin (1.6 μg/mm2) and probucol (0.8 μg/mm2). The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography (OCT) findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.
文摘Long coronary lesions are associated with adverse outcomes after percutaneous coronary intervention since the era of plain balloon angioplasty. Long lesion and long stent length are considered as important predictors of restenosis after percutaneous coronary intervention. With the advent of newer generation drug eluting stents, there has been dramatic reduction in the rates of restenosis and repeat revascularization, even in complex cohort of patients with long coronary lesions. We report one such case of long coronary lesion which was intervened successfully with newer generation, thin strut, biodegradable polymer coated sirolimus-eluting stents.
文摘Background There are limited data on the efficacy of drug-eluting stents (DES) for treatment of chronic total occlusions (CTO). The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent (BMS) implantation.Methods Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 (55.7%) who underwent DES and 524 (44.3%) who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events (MACE). Long-term survival rates were estimated with the Kaplan-Meier method.Results Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy ((7.4±2.5) months vs (1.7±0.8) months, P 〈0.001). Average follow-up periods were (4.7±0.89) and (3.2±1.3) years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups (90.3% for DES group vs 89.6% for BMS group, Log-rank P=0.38), but the 5-year target vessel revascularization (TVR)-free survival rate in the DES group was significantly higher than that in the BMS group (81.6% vs 73.5%, Log-rank P 〈0.001). The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group (80.6% vs 71.5%, Log-rank P〈0.001). The rates of readmission caused by cardiovascular disease (27.0% vs 37.8%, P 〈0.001) and the need for bypass surgery were significantly lower in the DES group (1.5% vs 3.4%, P 〈0.05). By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients (HR: 0.492; 95% Cl 0.396-0.656, P 〈0.001). Left ventricular ejection fraction 〈50% and elderly (〉65 years) were identified as independent predictors of long-term MACE during follow-up.Conclusion This study demonstrates the long-term (up to 5 years) efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.
文摘Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%' Small diameter renal artery is common in patients with congenital multi-branch renal arteries, diabetes and multi-coronary artery lesions. Renal artery bare-mental stent (BMS) implantation is the standard treatment for ostial renal
文摘Background Because no data regarding the comparison of crush stenting with paclitaxel (PES) or sirolimus eluting stents (SES) for coronary bifurcate lesions have been reported, we compared the clinical outcomes of these two types of stents. Methods Two hundred and thirty patients with 242 bifurcate lesions were enrolled in a prospective, nonrandomized trial Primary endpoints included myocardial infarction, cardiac death and target vessel revascularization at 8 months. Results All patients were followed up clinically and 82% angiographically at 8 months. Final kissing balloon inflation was performed in 72% in the PES and 75% in the SES groups (P〉0.05). Compared to the SES group, PES group had a higher late loss and incidence of restenosis (P=0.04) in the prebifurcation vessel segment. The postbifurcation vessel segment in the PES group had a greater late loss ((0.7±0.6) mm vs (0.3±0.4) mm, P〈0.001) and higher restenosis in the side branch (25.5% vs 15.6%, P=0.04) when compared to the SES group. There was significant difference of insegment restenosis in the entire main vessel between PES and SES groups (P=0.004). Target lesion revascularization was more frequently seen in the PES group as compared to the SES group (P=0.01). There was significant difference in the accumulative MACE between these two groups (P=-0.01). The survival rate free from target lesion revascularization was significantly higher in the SES group when compared to the PES group (P〈0.001). Conclusion SES is superior to PES in reducing restenosis and target lesion revascularization by 8-month follow-up after crush stenting for bifurcate lesions.
文摘Background Drug-eluting stents (DES) are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular the late and very late stent thrombosis rate compared to bare metal stents (BMS). The aim of the study was to compare the reported incidence of late and very late stent thrombosis of DES and BMS in patients from published clinical studies with an extended follow-up period to four years.Methods A search strategy was developed to identify publications reporting on late or very late thrombosis of BMS and DES available through MEDLINE and Cochrane Library databases. Two independent reviewers appraised eligible studies and extracted data. Odds ratios (OR) were calculated for each outcome and presented with 95% confidence intervals (CI).Results Fourteen randomized controlled trials, which were at least single blinded, were identified. There was no difference in the incidence of late and very late stent thrombosis in patients treated with DES compared with patients treated with BMS (late OR 0.55, 95%Cl 0.23-1.31 and late/very late OR=1.08, 95%CI 0.61-1.91).Conclusions The safety profile of DES was similar to BMS in terms of stent thrombosis. We found no evidence of increased risk of late and very late thrombosis for DES.
文摘Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG)in the patients with CTO and multivessel disease.Methods From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.Results At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% Cl 1.219-3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739-45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.Conclusions Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.
基金Supported by An unrestrictive grant from Sanofi-Aventis
文摘The objective of this study is to develop a cost-effectiveness model comparing drug eluting stents(DES) vs bare metal stent(BMS) in patients suffering of stable coronary artery disease. Using a 2-years time horizon, two simulation models have been developed: BMS first line strategy and DES first line strategy. Direct medical costs were estimated considering ambulatory and hospital costs. The effectiveness endpoint was defined as treatment success, which is the absence of major adverse cardiac events. Probabilistic sensitivity analyses were carried out using 10000 Monte-Carlo simulations. DES appeared slightly more efficacious over 2 years(60% of success) when compared to BMS(58% of success). Total costs over 2 years were estimated at 9303 € for the DES and at 8926 € for bare metal stent. Hence, corresponding mean cost-effectiveness ratios showed slightly lower costs(P < 0.05) per success for the BMS strategy(15520 €/success), as compared to the DES strategy(15588 €/success). Incremental costeffectiveness ratio is 18850 € for one additional percent of success. The sequential strategy including BMS as the first option appears to be slightly less efficacious but more cost-effective compared to the strategy including DES as first option. Future modelling approaches should confirm these results as further comparative data in stable coronary artery disease and long-term evidence become available.
文摘Atherosclerotic process has a predilection for .bifurcation due to the complex hemodynamics and resultant altered shear stress that contributes to the localization and progression of atheromatous plaques. Coronary intervention, especially the placement of stents further alters the hemodynamics and shear forces. These factors may account for the increased incidences of in-stent restenosis, stent thrombosis, side-branch (SB) restenosis, etc, that continue to plague bifurcation intervention.
文摘Objective To review the presentation,diagnosis and recent developments in the pharmacological and invasive treatment of ST elevation myocardial infarction (STEMI) with a special focus on health-care organization in order to increase accessibility of primary pemutaneous coronary intervention (PCI).Data sources Data were obtained from English publications on STEMI treatment.No formal systematic review was conducted,but an effort was made to be comprehensive.Study selection Studies were selected if they contained data relevant to the topic.Preferably,data from clinical randomized trials,meta-analyses,guidelines and a few recent reviews are referenced.Results The described clinical approach to acute myocardial infarction (AMI) has been a continuum of scientific results and translation into clinical practice over the last four decades since the advent of thrombolytic reperfusion.This has resulted in a dramatic in-hospital mortality decrease from 30% in the 1960s to the present 5%.The biggest survival benefits have undoubtedly been achieved after the advent of reperfusion strategies.In contemporary treatment of STEMI,additional treatment effects on survival have to be sought in the very early admission phase,as the current mortality hazard drops significantly after the first critical days to continuously very low levels after discharge.Conclusions Optimal treatment of STEMI patients is best performed with a widely accessible reperfusion strategy,preferably primary PCI,with contemporary peri-procedural anti-thrombotic treatment and device implantation.Accessibility of reperfusion strategies is increased by efficient STEMI networks applying prehospital triage with digital tele-transmission of electrocardiograms (ECGs) and seamless patient transitions between health-care unities.Efficient treatments of complicated STEMI with out-of hospital cardiac arrest and/or cardiogenic shock underline the necessity of structured referral systems,preferably immediately after the initial STEMI diagnosis。
文摘Background Early clinical trials with the Endeavor zotarolimus eluting stent (ZES) in western populations demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 5 years of follow-up. The aim of this clinical registry study was to evaluate real world clinical performance of the ZES coronary system in Chinese patients. Methods The China Endeavor Registry is a prospective, multicenter registry assessing the safety of the ZES system in a real world patient population. It was conducted at 46 centers in China in routine treatment of patients with coronary artery stenosis, including patients with clinical characteristics or lesion types that are often excluded from randomized controlled trials. The registry included 2210 adult patients who underwent single-vessel or multi-vessel percutaneous coronary intervention. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. Results The 12-month rate of MACE for all patients in the registry was 3.03%. Cardiac death or myocardial infarction rate was 1.28% and target lesion revascularization rate was 1.66%, non-target lesion target vessel revascularization (TVR) was 0.52%, TVR was 2.18%, and target vessel failure was 3.22%. There was only one case of emergent cardiac bypass surgery. The 12-month overall incidence of all Academic Research Consortium (ARC)-defined stent thrombosis was 0.43%. Conclusion Mid-term results from the real-world China Endeavor Registry suggest that Endeavor ZES was safe and effective in Chinese patients.
文摘Background Through a ministernotomy "J shaped approach, left internal mammary artery (LIMA) bypass grafting to the left anterior descending artery (LAD) can be performed safely off-pump. To achieve a complete revascularization, percutaneous coronary interventions (PCI) with drug eluting stent implantation to other coronary arteries was used. We reported outcomes of the treatment of multivessel coronary artery disease with minimally invasive coronary artery bypass (MICAB) and PCI. Methods Between January 2009 and Dec 2012, 14 patients (11 males, 3 females, mean age was 64.8 _ 10.1 years. Two-vessel disease account for 35.7% (5/14) of these patients, three-vessel disease 64.2% (9/14) (Table 1). All patients underwent a minimally invasive coronary artery bypass grafting via mini-sternotomy "J" shaped approach. Seven patients were followed by PCI, 7 for obtuse marginal circumflex, 5 for right coronary artery (RCA). Angiographic assessment of graft patency was performed in all patients during the PCI procedure. The clinical follow-up period lasts from 11-24 months. Results The in-hospital mortality was 0%. There was neither conversion to a full median sternotomy nor intraoperative complications. Ventilation time was 6.6 +_ 4.1 h. Blood loss ranged 341 +_ 78.8 mL. ICU stay ranged 22.3 _ 12.8 h. Hospital postoperative stay lasted for 6.5 + 1.6 days. Prior to PCI patients showed 100% patent left internal mammary artery. One patient had mediastinitis (Tables 2-3). Rate of freedom from cardiac reintervention during the follow-up period was 92.8% (13/14). Conclusions The inferior J-shaped sternotomy is simple, reproducible, and the safest technique for performing minimally invasive coronary bypass surgery. MICAB + PCI is also safe, feasible and efficacious.
文摘Background Patients with end-stage renal disease have a high mortality from coronary artery disease, but the impact of moderate renal insufficiency on clinical outcomes after percutaneous coronary intervention (PCI) and the effect of drug-eluting stent implantation in these patients remain unclear. This study determined the long-term effect of moderate renal insufficiency on death and major adverse cardiac events (MACE) after stent based PCI and examined whether drug-eluting stent implantation could favourably influence clinical outcome. Methods Major adverse cardiac events and causes of mortality were determined for 1012 patients undergoing percutaneous intervention from January 1, 2002 to December 31, 2004 at Shanghai Ruijin Hospital. Based on estimated creatinine clearance levels, long term outcomes were compared between patients with estimated creatinine clearance 〈60 ml/min (renal insufficiency group; n=410) and those with estimated creatinine clearance ≥60 ml/min (control group; n=602). Subgroup analysis was also made for patients with renal insufficiency between drug eluting stent (n=264) and bare metal stent implantation (n=146) during PCI. Results During follow-up (average 17 months) after successful PCI, all causes of death (7.1% vs 2.3%, P〈0.01) and cardiac death (3.4% vs 1.0%, all P〈0.01) were significantly higher in renal insufficiency group than in control group. For patients with moderate renal insufficiency, drug-eluting stent implantation reduced significantly all causes of death (5.3% vs 10.9%, P〈0.05) and occurrence of major cardiac adverse events (15.1% vs 24.6%, P〈0.05) compared with bare metal stents. Conclusions Moderate renal insufficiency is an important clinical factor influencing the mortality after PCI in patients with coronary artery disease and the use of drug-eluting stents should be the preferred therapy for the improvement of long-term outcomes in such patients.
文摘Background Lesions at coronary bifurcations always are a big challenge for interventionists even with the advent of drug eluting stents (DES). Even as more clinical trials are published, operators still can not confirm that one strategy is more efficient than another. Selection of patients and short term follow-up contribute to the difficulty in comparing strategies. Methods From April 2004 to April 2008, 505 consecutive Chinese patients underwent DES implantation for true bifurcation lesions; including 258 using crush strategy (213 male, (56.7+10.8) years old) and 247 using no crush strategy (206 male, (58.1+10.1) years old) were analyzed. Results The follow-up period ranged from 237 to 1223 days, average (537+340) days for the crush group and (538+351) days for the no crush group. There was no significant difference of major adverse cardiac events (MACE) rate between the two groups (10.1% vs 12.1%; P=-0.481), nor in cardiac death, nonfatal myocardial infarction (MI) or in the target vessel revascularization (TVR) (0.4% vs 1.6%; P=0.207, 2.7% vs 2.8; P=1.000 and 7.0% vs 7.7%; P=0.865). The stent thrombosis rate was similar in the two groups (1.6% vs 2.0%; P=0.409), late and very late stent thrombosis in both groups were very low (0.4% vs 0.4%; P=-1.000). Seven-month angiographic follow-up showed no significant difference of the restenosis rate between the two groups (11.0% vs 13.5%; P=0.786). During the follow-up, cardiac death, nonfatal MI, TVR and ST free survival rate showed no significant difference between the two groups. The only variant identified as a predictor of MACE was percutaneous coronary intervention (PCI) in the first two years, which accounted for 47% of patients of all cases in four years. Conclusion Crush technique showed similar long-term clinical effect compared with other two DES techniques for coronary bifurcation lesions, the surgeons' skills are very important for reducing clinical events.